Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders

The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.

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Key information

Conditions

Primary Immunodeficiency Diseases (PID) Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cytopenia Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Immune Thrombocytopenic Purpura (ITP) Immunologic Deficiency Syndromes Kawasaki Syndrome Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Primary Immunodeficiency Diseases Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Thrombocytopenia Thrombotic Microangiopathies Vascular Diseases Vasculitis

Age range

24 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Children´s Hospital Los Angeles, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent obtained from either the subject or the subject's legally acceptable representative prior to any study-related procedures and study product administration
Diagnosis of a PID disorder as defined by World Health Organization criteria for which the subject has been receiving a regimen of IGIV infusions every 21 to 28 days over a period of at least 4 months pre-study at a dose of 300-600 mg/kg body weight
Subjects > 24 months of age
A negative serum pregnancy test for any female subject who is of childbearing potential.

Exclusion criteria

Subjects sero-positive at enrollment for one or more of the following: hepatitis B surface antigen (HBsAg), antibodies to hepatitis C virus (HCV), antibodies to human immunodeficiency virus (HIV) Types 1 or 2
Subjects with levels of alanine amino transferase (ALT) and aspartate amino transferase (AST) > 2.5 times the upper limit of normal for the testing laboratory. An AST > 2.5 times the upper limit of normal is allowable, if the ALT does not exceed the upper limit of the reference range for the testing laboratory
Subjects with neutropenia (defined as an ANC >= 1,000/mm3)
Subjects with serum creatinine levels greater than two times the upper limit of normal for age and gender
Subjects with malignancy or a history of malignancy
Subjects who received any blood or blood product exposure other than an IGIV and/or immune serum globulin (ISG) preparation within the 6 months prior to study entry
Subjects with an ongoing history of hypersensitivity or persistent reactions (urticaria, breathing difficulty, severe hypotension, or anaphylaxis) following IGIV and/or ISG infusions
Subjects with selective complete IgA deficiency
Subjects with moderate levels of anti-IgA antibodies (>150), or subjects with lower anti-IgA antibodies who are naive to IGIV treatment. (Subjects with lower levels of IgA antibodies, whom the investigators know to have tolerated IgA containing IGIV preparations in the past, may be included if the investigator is comfortable with this)
Subjects receiving antibiotic therapy for the treatment of infection within 30 days prior to enrollment
Subjects who receive prophylactic antibiotics as part of their care regimen
Subjects participating in another clinical study involving an investigational product or device within 30 days prior to study entry

Treatment and study plan

Immune Globulin Intravenous (Human), 10%

Biological

Primary outcomes

Mean number of acute serious bacterial infections per participant per year

Time frame: Throughout the study period of 18 months

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Registry information

Official study title

A Clinical Investigation to Assess the Safety and Efficacy of Immune Globulin Intravenous (Human), 10% in Subjects With Primary Immunodeficiency Disorders

Important dates

Study start: 2002
Primary completion: 2003
Study completion: 2003
First posted: Sep 12, 2005
Registry last updated: Aug 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed